Transcription of HIGHLIGHTS OF PRESCRIBING INFORMATION GADAVIST. …
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HIGHLIGHTS OF PRESCRIBING INFORMATION GADAVIST. …
HIGHLIGHTS OF PRESCRIBING INFORMATION These HIGHLIGHTS do not include all the INFORMATION needed to use GADAVIST safely and effectively. See full PRESCRIBING INFORMATION for GADAVIST. GADAVIST (gadobutrol) injection, for intravenous use Initial Approval: 2011 WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF) See full PRESCRIBING INFORMATION for complete boxed warning Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic INFORMATION is essential and not available with non-contrasted MRI or other modalities. The risk for NSF appears highest among patients with: o Chronic, severe kidney disease (GFR < 30 mL/ ), or o Acute kidney injury.
See full prescribing information for complete boxed warning . Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non -contrasted MRI or other modalities. •
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